ClinicalTrials.Veeva

Menu

Ischaemia-réperfusion During the Coronary Surgery With Beating Heart

U

University Hospital, Strasbourg, France

Status and phase

Unknown
Phase 3

Conditions

Ischaemia-reperfusion Injury

Treatments

Drug: Diltiazem
Drug: Placebo
Drug: diltiazem and acetylcystein
Drug: Acetylcystein

Study type

Interventional

Funder types

Other

Identifiers

Details and patient eligibility

About

Less oxidative stress occurs during off-pump than on-pump coronary artery bypass graft (CABG) surgery but warm ischaemia-reperfusion injury may occur following transient coronary artery clamping. The aim of this study was to compare the preventive effects of diltiazem and N-acetylcysteine (NAC), alone or in combination, on biomarkers of myocardial damage and oxidative stress during off-pump CABG surgery.

Enrollment

120 estimated patients

Sex

All

Ages

60 to 80 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • Age included between 60 and 80 years

Exclusion criteria

  • Age < 60 or > 80 years
  • Pregnancy
  • The allergy in used medicines (N-acétylcystéine, Diltiazem)
  • Presence of a pathology valvulaire associated
  • Urgency
  • Unstable angor
  • Bypass as a matter of urgency
  • Recours peropératoire to a CEC
  • FE < 0,40
  • BAV of the 2nd and 3rd not sailed degree
  • fibrillation or flutter little finger.

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

120 participants in 4 patient groups, including a placebo group

Arm1: control group
Placebo Comparator group
Description:
Received 250 ml of a 5% dextrose solution as placebo drug
Treatment:
Drug: Placebo
Arm 2: diltiazem group
Experimental group
Description:
Received a 100 µg/kg bolus followed by a 0.3 µg/kg infusion diluted in 250 ml of 5% dextrose solution
Treatment:
Drug: Diltiazem
Arm 3: acetylcystein group
Experimental group
Description:
Received 150 mg/kg acetylcystein diluted in 250 ml of 5% dextrose solution
Treatment:
Drug: Acetylcystein
Arm 4: diltiazem and acetylcystein group
Experimental group
Description:
Received a combination of drug : bolus diltiazem 100 µg/kg followed by a 0.3 µg/kg infusion diluted in 125 ml of a 5% dextrose solution and 150 mg/kg acetylcystein diluted in 125 ml of 5% dextrose solution
Treatment:
Drug: diltiazem and acetylcystein

Trial contacts and locations

1

Loading...

Data sourced from clinicaltrials.gov

Clinical trials

Find clinical trialsTrials by location
© Copyright 2024 Veeva Systems